First ophthalmology biosimilar approved in US

Samsung Bioepis and Biogen have secured FDA approval for Byooviz (ranibizumab-nuna), the first ophthalmology biosimilar approved in the US.

Byooviz is a biosimilar referencing Lucentis (ranibizumab) and has been approved for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

Ranibizumab is an anti-vascular endothelial growth factor (VEGF) therapy that prevents vision loss in patients with retinal vascular disorders which can cause irreversible blindness or visual impairments in adults in the US.

In addition to the US approval, Byooviz was approved in Europe, including 27 EU member countries on August 18, 2021 and the UK on August 31, 2021.

Samsung Bioepis and Biogen entered into a commercialisation agreement for two ophthalmology biosimilar candidates, SB11, a biosimilar candidate referencing Lucentis (ranibizumab) and SB15, a biosimilar candidate referencing Eylea (aflibercept), in November 2019.

Developed by Samsung Bioepis, SB11 will be commercialized under the brand name Byooviz by Biogen in the United States.

Pursuant to a global license agreement entered into with Genentech, Samsung Bioepis and Biogen will have freedom to market SB11 in the United States as of June 2022, i.e., before expiration of Genentech’s applicable SPCs, and elsewhere in other territories after expiration of Genentech’s SPCs.

The FDA approval of Byooviz was based on a totality of evidence including analytical, non-clinical data, and clinical data.

Byooviz is Samsung Bioepis’ fifth biosimilar approved in the US.

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